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New Drug Applications

The New Drug Application (NDA) is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States.
The purpose of a NDA is to provide enough information to permit the FDA to reach the following key decisions

  • Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks
  • Whether the drug's proposed labeling (package insert) is appropriate and what it should contain
  • Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity

For more information on New Drug Applications, please visit the FDA's How Drugs are Developed and Approved page.


Company: Radius Health, Inc.
Treatment for: Osteoporosis

Abaloparatide is a synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein) in development for the treatment of postmenopausal women with osteoporosis.

Rayaldee (calcifediol)

Company: OPKO Health, Inc.
Treatment for: Secondary Hyperparathyroidism

Rayaldee (calcifediol modified-release) is a first-in-class oral vitamin D prohormone treatment in development for secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease and vitamin D insufficiency.

telotristat etiprate

Company: Lexicon Pharmaceuticals, Inc.
Treatment for: Carcinoid Syndrome

Telotristat etiprate is an oral tryptophan hydroxylase inhibitor in development for the treatment of carcinoid syndrome.

Nuplazid (pimavanserin)

Company: Acadia Pharmaceuticals Inc.
Treatment for: Parkinson’s Disease Psychosis

Nuplazid (pimavanserin) is a selective serotonin inverse agonist (SSIA) in development for the treatment of psychosis associated with Parkinson’s disease.

Xadago (safinamide)

Company: Newron Pharmaceuticals S.p.A.
Treatment for: Parkinson's Disease

Xadago (safinamide) is an alpha-aminoamide in development as an add-on therapy to dopamine agonists or to levodopa in patients with early or mid- to late-stage Parkinson’s disease.

crisaborole Topical Ointment

Company: Anacor Pharmaceuticals, Inc.
Treatment for: Atopic Dermatitis

Crisaborole is a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the treatment of mild-to-moderate atopic dermatitis.

SequestOx (naltrexone and oxycodone hydrochloride)

Company: Elite Pharmaceuticals, Inc.
Treatment for: Pain

SequestOx (oxycodone hydrochloride and naltrexone) is an abuse-deterrent opioid formulation in development for the management of moderate to severe pain.

Travivo (gepirone)

Company: Fabre-Kramer Pharmaceuticals Inc. and GlaxoSmithKline
Treatment for: Depression

Travivo (gepirone extended-release) is an investigational azapirone antidepressant in development for the treatment of adults with major depressive disorder.

Yosprala (aspirin and omeprazole)

Company: Aralez Pharmaceuticals Inc.
Treatment for: Ischemic Stroke -- Prophylaxis, Gastric Ulcer Prophylaxis

Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination in development for the secondary prevention of cardiovascular disease in patients at risk for aspirin-associated gastric ulcers.

iclaprim Intravenous Injection

Company: Motif Bio plc
Treatment for: Skin and Structure Infection

Iclaprim is an investigational broad-spectrum diaminopyrimidine antibiotic in development for the treatment of acute bacterial skin and skin structure infections (ABSSSIs).

Arymo ER (morphine sulfate) Extended-Release Tablets

Company: Egalet Corporation
Treatment for: Pain

Arymo ER (morphine sulfate) is an extended-release, abuse-deterrent, opioid analgesic formulation in development for the management of severe pain.

insulin glargine and lixisenatide

Company: Sanofi
Treatment for: Diabetes Type 2

Insulin glargine and lixisenatide is an insulin and glucagon-like peptide-1 receptor agonist (GLP-1 RA) fixed-ratio combination in development for the treatment of adults with type 2 diabetes.

EOquin (apaziquone)

Company: Spectrum Pharmaceuticals, Inc.
Treatment for: Bladder Cancer

EOquin (apaziquone) is an indolequinone bioreductive prodrug and analog of mitomycin C for intravesical instillation in the treatment of non-muscle invasive bladder cancer.

Firdapse (amifampridine phosphate)

Company: Catalyst Pharmaceuticals, Inc.
Treatment for: Lambert Eaton Myasthenic Syndrome (LEMS); Congenital Myasthenic Syndromes (CMS)

Firdapse (amifampridine phosphate) is a neuronal potassium channel blocker in development for the treatment of Lambert Eaton myasthenic syndrome (LEMS) and congenital myasthenic syndromes (CMS).

andexanet alfa

Company: Portola Pharmaceuticals, Inc.
Treatment for: Reversal of Anticoagulant Activity of Factor Xa Inhibitors

Andexanet alfa is a recombinant protein designed to reverse the anticoagulant effect in patients treated with oral or injectable Factor Xa inhibitors.


Company: Celltrion
Treatment for: Crohn's Disease -- Acute, Ulcerative Colitis, Rheumatoid Arthritis

CT-P13 is a proposed biosimilar to Remicade (infliximab) in development for the treatment of autoimmune diseases, including Crohn's disease, ulcerative colitis and rheumatoid arthritis.

See also: Generic Approvals, New Drug Approvals, Recent Additions to Rxmed, Alphabetical Listing of all New Drug Applications, FDA Approval Process

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